Gvoke Pfs is a drug owned by Xeris Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 22, 2036. Details of Gvoke Pfs's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9649364 | Methods for producing stable therapeutic formulations in aprotic polar solvents |
Apr, 2036
(9 years from now) | Active |
| US11590205 | Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents |
Apr, 2036
(9 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Gvoke Pfs's patents.
Latest Legal Activities on Gvoke Pfs's Patents
Given below is the list of recent legal activities going on the following patents of Gvoke Pfs.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 06 Nov, 2024 | US9649364 |
| Recordation of Patent Grant Mailed
Critical | 28 Feb, 2023 | US11590205 |
| Patent Issue Date Used in PTA Calculation
Critical | 28 Feb, 2023 | US11590205 |
| Email Notification
Critical | 28 Feb, 2023 | US11590205 |
| Issue Notification Mailed
Critical | 08 Feb, 2023 | US11590205 |
| Application Is Considered Ready for Issue
Critical | 24 Jan, 2023 | US11590205 |
| Dispatch to FDC | 24 Jan, 2023 | US11590205 |
| Mail Response to 312 Amendment (PTO-271)
Critical | 23 Jan, 2023 | US11590205 |
| Email Notification
Critical | 23 Jan, 2023 | US11590205 |
| Response to Amendment under Rule 312
Critical | 13 Jan, 2023 | US11590205 |
FDA has granted several exclusivities to Gvoke Pfs. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Gvoke Pfs, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Gvoke Pfs.
Exclusivity Information
Gvoke Pfs holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Gvoke Pfs's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 10, 2022 |
US patents provide insights into the exclusivity only within the United States, but
Gvoke Pfs is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Gvoke Pfs's family patents as well as insights into
ongoing legal events
on those patents.
Gvoke Pfs's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Gvoke Pfs:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Gvoke Pfs's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 22, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gvoke Pfs Generic API suppliers:
Glucagon is the generic name for the brand Gvoke Pfs. 4 different companies have already filed for the generic of Gvoke Pfs, with Amphastar Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gvoke Pfs's generic
Alternative Brands for Gvoke Pfs
Gvoke Pfs which is used for treating severe hypoglycemia., has several other brand drugs in the same treatment category and using the same active ingredient (Glucagon). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Xeris |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Glucagon. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Amphastar Pharms Inc |
| ||
| Zealand Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Glucagon, Gvoke Pfs's active ingredient. Check the complete list of approved generic manufacturers for Gvoke Pfs
About Gvoke Pfs
Gvoke Pfs is a drug owned by Xeris Pharmaceuticals Inc. It is used for treating severe hypoglycemia. Gvoke Pfs uses Glucagon as an active ingredient. Gvoke Pfs was launched by Xeris in 2025.
Approval Date:
Gvoke Pfs was approved by FDA for market use on 14 March, 2025.
Active Ingredient:
Gvoke Pfs uses Glucagon as the active ingredient. Check out other Drugs and Companies using Glucagon ingredient
Treatment:
Gvoke Pfs is used for treating severe hypoglycemia.
Dosage:
Gvoke Pfs is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG/0.1ML (0.5MG/0.1ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 1MG/0.2ML (1MG/0.2ML) | SOLUTION | Prescription | SUBCUTANEOUS |